EverFlex Post Approval Study (DURABILITY PAS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Covidien
Sponsor:
Information provided by (Responsible Party):
Covidien
ClinicalTrials.gov Identifier:
NCT01680835
First received: September 4, 2012
Last updated: November 14, 2013
Last verified: November 2013
  Purpose

This post-approval study is designed to confirm the long-term safety and effectiveness of the EverFlex™ Self-Expanding Stent System for the treatment of atherosclerotic superficial femoral artery (SFA) and proximal popliteal arteries.


Condition Intervention
Peripheral Arterial Disease
Lower Extremity Arterial Disease
Device: EverFlex™ Self-Expanding Peripheral Stent System

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The US StuDy for EvalUating EndovasculaR TreAtments of Lesions in the Superficial Femoral Artery and Proximal Popliteal By usIng the EverfLex NitInol STent System Post Approval Study

Resource links provided by NLM:


Further study details as provided by Covidien:

Primary Outcome Measures:
  • Primary Outcome - Composite endpoint [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
    Composite endpoint defined as freedom from acute death, freedom from 36-month amputation, and freedom from 36-month clinically-driven target lesion revascularization compared to a PTA performance goal.


Estimated Enrollment: 169
Study Start Date: September 2012
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Study cohort
All patients enrolled in this study will be treated with the EverFlex™ Self-Expanding Peripheral Stent System.
Device: EverFlex™ Self-Expanding Peripheral Stent System
Using the EverFlex™ Self-Expanding Peripheral Stent System to treat

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Is willing to comply with all follow-up evaluations at the specified times.
  • Is at least 18 years old.
  • Provides written informed consent prior to enrollment in the study.

Exclusion Criteria:

  • Has any co-morbid condition that precludes endovascular treatment.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01680835

Contacts
Contact: Stephanie Brucato, CCRA Stephanie.Brucato@Covidien.com

Locations
United States, Arizona
St. Luke's Medical Center Recruiting
Phoenix, Arizona, United States, 85006
Principal Investigator: Richard Heuser, MD         
United States, California
Sutter Memorial Hospital Recruiting
Sacramento, California, United States, 95819
Principal Investigator: David Roberts, MD         
United States, Florida
First Coast Cardiovascular Institute, P.A. Recruiting
Jacksonville, Florida, United States, 32216
Principal Investigator: Yazan Khatib, MD         
United States, Georgia
Vascular Radiology Associates Recruiting
Augusta, Georgia, United States, 30904
Principal Investigator: Samuel Mietling, MD         
United States, Illinois
Dupage Medical Group Recruiting
Lombard, Illinois, United States, 60148
Principal Investigator: Norman Kumins, MD         
Rockford Cardiovascular Associates Recruiting
Rockford, Illinois, United States, 61107
Principal Investigator: Jan Skowronski, MD         
United States, Iowa
Central Iowa Hospital Corporation Recruiting
West Des Moines, Iowa, United States, 50266
Principal Investigator: Eric Scott, MD         
United States, Michigan
Sparrow Clinical Research Institute Recruiting
Lansing, Michigan, United States, 48912
Principal Investigator: Alonso Collar, MD         
William Beaumont Hospital Recruiting
Royal Oak, Michigan, United States, 48073
Principal Investigator: Terry Bowers, MD         
United States, Minnesota
Metropolitan Cardiology Consultants Recruiting
Coon Rapids, Minnesota, United States, 55433
Principal Investigator: Daniel Dulas, MD         
United States, New Jersey
Deborah Heart and Lung Center Recruiting
Browns Mills, New Jersey, United States, 08015
Principal Investigator: Kane Chang, MD         
United States, North Carolina
Wake Heart Research Recruiting
Raleigh, North Carolina, United States, 27610
Principal Investigator: Ravish Sachar, MD         
United States, Oklahoma
Oklahoma Heart Institute Recruiting
Tulsa, Oklahoma, United States, 74104
Principal Investigator: Raj Chandwaney, MD         
United States, Pennsylvania
Bryn Mawr Hospital Recruiting
Bryn Mawr, Pennsylvania, United States, 19010
Principal Investigator: Antonis Pratsos, MD         
United States, South Dakota
Sanford Research USD Recruiting
Sioux Falls, South Dakota, United States, 57117
Principal Investigator: Greg Schultz, MD         
United States, Tennessee
Premier Surgical Associates Recruiting
Knoxville, Tennessee, United States, 37909
Principal Investigator: Christopher Pollock, MD         
United States, Texas
University of Texas Health Science Center at San Antonio Recruiting
San Antonio, Texas, United States, 78229
Principal Investigator: Anand Prasad, MD         
United States, Wisconsin
Cardiology Associates of Bellin Health Recruiting
Green Bay, Wisconsin, United States, 54301
Principal Investigator: Christopher Wolfram, MD         
Sponsors and Collaborators
Covidien
Investigators
Principal Investigator: Jon S Matsumura, MD University of Wisconsin, Madison
Principal Investigator: Krishna Rocha-Singh, MD Priarie Heart Institute
  More Information

No publications provided

Responsible Party: Covidien
ClinicalTrials.gov Identifier: NCT01680835     History of Changes
Other Study ID Numbers: CP-1001
Study First Received: September 4, 2012
Last Updated: November 14, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Menthol
Antipruritics
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 01, 2014